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Mucoderm or Connective Tissue Graft for Treatment of Gingival Recessions

Primary Purpose

Gingival Recession

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Root coverage with collagen matrix graft
Root coverage with subepithelial connective tissue graft
Basic periodontal treatment
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring clinical trial, root coverage, biomaterials, collagen matrix, coronally advanced flap

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • CEJ without significant damage;
  • localized bilateral RT1 gingival recession ≥3 mm in the same arch

Exclusion Criteria:

  • previous periodontal surgical treatment on the involved sites;
  • smokers
  • pregnants or lactating
  • compromised systemic health and contraindications for periodontal surgery

Sites / Locations

  • School of Dentistry of Ribeirao Preto - University of Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Test Group

Control Group

Arm Description

Active comparator: gingival recession the aim of this study is to compare if the collagen matrix graft is as efficient as a substitute for the connective graft used in root coverage of gingival recessions

the aim of this study is to compare if the collagen matrix graft is as efficient as a substitute for the connective graft used in root coverage of gingival recessions. The control group was treated with the same technique as the collagen matrix graft.

Outcomes

Primary Outcome Measures

Root coverage after 6 months
Root coverage is measured by the difference between the gingival recession height at 6 months and baseline

Secondary Outcome Measures

Keratinized tissue gain after 6 months
The difference between keratinized tissue width and depth at 6 months and at baseline

Full Information

First Posted
September 10, 2018
Last Updated
September 14, 2018
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03675334
Brief Title
Mucoderm or Connective Tissue Graft for Treatment of Gingival Recessions
Official Title
Clinical Comparison Between the Use of a Connective Tissue Graft or a Porcine Collagen Matrix (Mucoderm) for Treatment of Gingival Recessions Type 1: a Randomized Controlled Clinical Study.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2016 (Actual)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Coronally advanced flap plus connective tissue graft (CTG) is the gold standard therapy for root coverage. The bioabsorbable porcine collagen matrix (CM) has been widely used in periodontal and mucogingival surgery as a substitute for CTG and has achieved similar results. The CM has the advantage of no need of a second surgical area and availability overcoming the limitations of donor site in autograft. The aim of this study is to investigate the use of Mucoderm® in root coverage procedures combined with extended coronally positioned flap (ECAF), test group (TG), in comparison to the connective tissue graft associated with the ECAF, control group (CG).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
clinical trial, root coverage, biomaterials, collagen matrix, coronally advanced flap

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Split-mouth clinical trial
Masking
InvestigatorOutcomes Assessor
Masking Description
The clinical parameters were screened by one single examiner that was not aware of the procedures
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test Group
Arm Type
Active Comparator
Arm Description
Active comparator: gingival recession the aim of this study is to compare if the collagen matrix graft is as efficient as a substitute for the connective graft used in root coverage of gingival recessions
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
the aim of this study is to compare if the collagen matrix graft is as efficient as a substitute for the connective graft used in root coverage of gingival recessions. The control group was treated with the same technique as the collagen matrix graft.
Intervention Type
Procedure
Intervention Name(s)
Root coverage with collagen matrix graft
Intervention Description
at one side, the root coverage have been done with a extended flap technique and collagen matrix graft. At the other side, the same technique was performed with connective graft.
Intervention Type
Procedure
Intervention Name(s)
Root coverage with subepithelial connective tissue graft
Intervention Description
at one side, the root coverage have been done with a extended flap technique and collagen matrix graft. At the other side, the same technique was performed with connective graft.
Intervention Type
Other
Intervention Name(s)
Basic periodontal treatment
Intervention Description
profilaxis, coronary polishing and scaling and root planning
Primary Outcome Measure Information:
Title
Root coverage after 6 months
Description
Root coverage is measured by the difference between the gingival recession height at 6 months and baseline
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Keratinized tissue gain after 6 months
Description
The difference between keratinized tissue width and depth at 6 months and at baseline
Time Frame
6months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: CEJ without significant damage; localized bilateral RT1 gingival recession ≥3 mm in the same arch Exclusion Criteria: previous periodontal surgical treatment on the involved sites; smokers pregnants or lactating compromised systemic health and contraindications for periodontal surgery
Facility Information:
Facility Name
School of Dentistry of Ribeirao Preto - University of Sao Paulo
City
Ribeirão Preto
State/Province
Sao Paulo
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32382931
Citation
Suzuki KT, de Jesus Hernandez Martinez C, Suemi MI, Palioto DB, Messora MR, de Souza SLS, Novaes AB Jr, Chaves Furlaneto FA, Taba M Jr. Root coverage using coronally advanced flap with porcine-derived acellular dermal matrix or subepithelial connective tissue graft: a randomized controlled clinical trial. Clin Oral Investig. 2020 Nov;24(11):4077-4087. doi: 10.1007/s00784-020-03280-x. Epub 2020 May 7.
Results Reference
derived

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Mucoderm or Connective Tissue Graft for Treatment of Gingival Recessions

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